BAHRAIN
BAHRAIN
Medwisdom Lifescience delivers full NHRA-compliant Regulatory Affairs services for Bahrain — including local scientific office, GCC-DR & national submissions, Arabic labeling, pricing approval, medical device registration, and complete lifecycle management.
Overview
Regulatory Affairs in Bahrain are overseen by the National Health Regulatory Authority (NHRA). As a GCC member, Bahrain accepts both the centralized GCC-DR procedure and direct national submissions. All registrations are 100% electronic via the NHRA e-services portal in eCTD/NeeS format.
Arabic labeling is mandatory, and final registration is only issued after pricing approval by the NHRA Pricing Committee.
Registration Process for Drugs and Medical Devices
Two pathways available:
- GCC Centralized Procedure (GCC-DR)
Single submission → approval valid in all GCC states including Bahrain - National Bahrain Route
Faster for generics and products already registered in another GCC country - Medical Devices & IVDs
Risk-based classification → Technical file submission → MDMA certificate valid for 5 years
Tentative Registration Timelines (2025)
| Pathway / Product | Timeline |
|---|---|
| GCC-DR Centralized (New Drugs) | 12–18 months |
| GCC-DR Generics | 8–12 months |
| National Bahrain Route (with GCC reference) | 4–8 months |
| Medical Devices (Low–Medium Risk) | 3–6 months |
| Medical Devices (High Risk) | 6–12 months |
| Cosmetics Notification | 1–2 months |
| Renewals / Variations | 3–6 months |
Challenges in Bahrain Regulatory Affairs
Common hurdles include:
- Mandatory Bahraini local scientific office with registered pharmacist
- Full Arabic labeling and patient information leaflet required
- Pricing committee approval required before final registration
- Legalised CPP, GMP, and FSC certificates
- Zone IVB stability data mandatory
- Occasional portal maintenance and validation updates
Medwisdom overcomes every challenge with our Manama office, native Arabic team, and flawless NHRA submission history.
Our Regulatory Affairs Services for Bahrain
- Local Scientific Office
NHRA-registered Bahrain entity & pharmacist - GCC-DR & National Submissions
eCTD/NeeS expertise - Arabic Labeling & Artwork
Native medical translation & mock-ups - Pricing Applications
Full pricing dossier & committee support
- Medical Device MDMA Registration
- Cosmetics & Supplements Notification
- Variations, Renewals, Transfers
- Regulatory Intelligence & GCC Updates
Why Choose Medwisdom for Bahrain Regulatory Affairs
- Manama-based office with direct NHRA relationships
- NHRA-registered local scientific office included
- 15+ years of 100% first-time-right submissions
- Native Arabic medical & regulatory translation team
- Expertise in both GCC-DR and fast national routes
- Complete pricing approval support
- Real-time portal monitoring & immediate query response
- Weekly updates and fully transparent project tracking
Key Official Regulatory Resources – Bahrain
- NHRA e-Services Portal
Electronic submissions & tracking
nhra.bh/eServices - National Health Regulatory Authority
All guidelines & circulars
www.nhra.bh - GCC Centralized Registration (GHAD)
Unified GCC-DR system
ghad.ae